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HI-CHART: A Phase I/II Study on the Feasibility of High-Dose Accelerated Conformal Radiotherapy in Patients With Inoperable Non-Small Cell Lung Cancer.

Phase 1/Phase 2
18 Years
Not Enrolling
Non-Small-Cell Lung Carcinoma

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Trial Information

HI-CHART: A Phase I/II Study on the Feasibility of High-Dose Accelerated Conformal Radiotherapy in Patients With Inoperable Non-Small Cell Lung Cancer.

Non-small cell lung cancer is still the most common cancer and the main cause of cancer
death. Treatment of choice for these patients is often radiotherapy, which results in an
overall 5-year survival rate between 5 and 10%. The addition of chemotherapy improves
survival by a few percentages and is therefore considered standard treatment for patients
with stage III disease.

However, several factors have been identified that have an impact on the local control but
also on survival.

1. There is a dose-effect relationship. A higher dose results in a better survival rate.
However, higher radiation doses are currently not delivered with conventional radiation
due to the tolerance of normal tissue.

2. The time factor plays an important role in radiotherapy. Prolonging the overall
treatment time decreases the outcome of radiotherapy. Radiobiological modelling of data
shows that the overall treatmetn time (OTT) should be kept below 4 weeks. Results from
studies support this conclusion.

So, probably the best results will be achieved when a very high radiation dose can be
delivered within 4 weeks, without severally damaging normal tissue.

In order to achieve this goal, an hyperfractionated accelerated treatment regimen together
with a technically very advanced radiation technique to avoid as much normal tissue as
possible, will be used in this study.

Inclusion Criteria:

histological or cytological diagnosis of non-small cell lung cancer stage I-III disease,
except supra-clavicular lymph nodes availability for participating in the detailed
follow-up of the protocol able to tolerate a radiation course according to the protocol
guidelines in case of previous chemotherapy, radiotherapy can start after a minimum of 3
weeks after the last CT course good performance status: Karnofsky>=70%, WHO performance
status 0-2 adequate lung functions allowing the radiation according to the guidelines
protocol no severe recent cardiac disease absence of any psychological, familial,
sociological or geographical condition potentially hampering compliance with the study
protocol and follow-up schedule; conditions should be discussed with the patient before
registration in the trial -

Exclusion Criteria:

patients who have a peripherally located lower lobe tumor and contralateral upper
mediastinal nodes malignant pleural or pericardial effusion concurrent chemotherapy
programs history of a prior malignancy excluding non melanoma skin cancer or in-situ
cancer history of prior chest irradiation recent myocardial infraction uncontrolled
infectious disease distant metastases (stage IV)


Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

acute toxicity

Principal Investigator

Rinus Wanders, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht Radiation Oncology (MAASTRO clinic)


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

December 2001

Completion Date:

December 2007

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • radiotherapy
  • radiation dose
  • lung cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms